Cleared Traditional

K820044 - ARTERIAL BLOOD FILTER, #AF-1025

K820044 is an FDA 510(k) clearance for ARTERIAL BLOOD FILTER, manufactured by Bentley Laboratories, Inc.. The device is a Class 2 Cardiovascular device with product code DTM cleared through the Traditional 510(k) pathway after a 173-day FDA review.

K820044 · Bentley Laboratories, Inc. · Cardiovascular device
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Jun 1982
Decision
173d
Days
Class 2
Risk

K820044 is an FDA 510(k) clearance for the ARTERIAL BLOOD FILTER, #AF-1025. Classified as Filter, Blood, Cardiopulmonary Bypass, Arterial Line (product code DTM), Class II - Special Controls.

Submitted by Bentley Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 29, 1982 after a review of 173 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4260 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Bentley Laboratories, Inc. devices

FDA 510(k) Submission Details - K820044

510(k) Number K820044 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 1982
Decision Date June 29, 1982
Days to Decision 173 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d slower than avg
Panel avg: 125d · This submission: 173d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTM Device Classification - Class 2, Special Controls

Product Code DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4260
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line

All 86
Devices cleared under the same product code (DTM) and FDA review panel - the closest regulatory comparables to K820044.
ARTERIAL BLOOD FILTER AF-1040-AF-1040BL
K830132 · American Bentley · Jan 1983
INTERSEPT PEDIACTRIC EXTRACORPOREAL FILT
K823108 · Extracorporeal Medical Specialities, Inc. · Nov 1982
INTERFACE ARTERIAL BLOOD FILTER #40
K823258 · Medical, Inc. · Nov 1982
ARTERIAL BLOOD FILTER MODEL #AF-1040
K820343 · Bentley Laboratories, Inc. · Jun 1982
PEDIATRIC ARTERIAL BLOOD FILTER #AF-540
K820679 · Bentley Laboratories, Inc. · Jun 1982
WILLIAM HARVEY H-625 ARTERIAL FILTER
K820472 · C.R. Bard, Inc. · Mar 1982